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This is a phase IIa, multicenter ,randomized, double-blind, Double-Dummy, Active- and placebo-controlled study designed to evaluate the efficacy, safety and kinetic characteristics of TRD205 tablets for postoperative analgesia after unilateral hip arthroplasty
This study used Active and placebo as a control to explore the efficacy, safety and pharmacokinetic characteristics of multiple administration of different doses of TRD205 tablets for postoperative analgesia after unilateral total hip replacement surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200mg treatment group | Experimental | TRD205 Tablets (Low Dose) |
|
| 400mg treatment group | Experimental | TRD205 Tablets (Middle Dose) |
|
| 600mg treatment group | Experimental | TRD205 Tablets (High Dose) |
|
| Active Control (Celecoxib) | Active Comparator | Celecoxib Capsules |
|
| Placebo Control | Placebo Comparator | Placebo for TRD205 and Celecoxib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRD205 Tablets, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 doses | Drug | First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the pain intensity-time curve (AUC0-48h) of resting pain NRS from 0 to 48 hours after surgery | 0 to 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of resting pain NRS at 0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively | 0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively | |
| AUC of movement pain NRS at 0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively | 0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiaohong zhang Beijing Tide Pharmaceutical Co., Ltd | Contact | 86-10-6788-0648-5064 | zhangxh3@tidepharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 130021 | China |
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| TRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 doses | Drug | First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime) |
|
| TRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 doses | Drug | First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime) |
|
| Celecoxib, oral; 400 mg initial dose, then 200 mg q12h; total 4 doses | Drug | First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime) |
|
| Matching placebo tablets and capsules, same dosing schedule | Drug | First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime) |
|
| Cumulative morphine-equivalent rescue analgesic dose at 0-4, 0-6, 0-12, 0-24, 0-48 hours | 0-4, 0-6, 0-12, 0-24, 0-48 hours after surgery |
| Time to first rescue analgesia | Within 48 hours after the surgery, the period from the end of the surgery to the first administration of analgesic medication for relief purposes |
| Number and proportion of participants using rescue analgesia | 0-48 hours postoperatively |
| Participant and investigator satisfaction with analgesia with the 5-point scale,the score range from 0 to 4, where 0 indicates poor, 1 indicates average, 2 indicates good, 3 indicates very good, and 4 indicates excellent. | At 48 hours after the surgery, the participants and the research doctors respectively evaluated the overall pain relief satisfaction of the test drug used on a 5-point scale, with the score range from 0 to 4, where 0 indicates poor, 1 indicates average, 2 indicates good, 3 indicates very good, and 4 indicates excellent. | 48 hours postoperatively |
| By evaluating security metrics such as AEs, SAEs and TEAEs to evaluate the safety of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty. | 5 days |
| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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